NCT03745053

XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Cardionovum GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty

Detailed description

The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Xlimus DES Implantation during coronary angioplasty	Xlimus DES Implantation during coronary angioplasty
DEVICE	Synergy DES Implantation during coronary angioplasty	Synergy DES Implantation during coronary angioplasty

Timeline

• Start date: 2019-02-05
• Primary completion: 2023-09-02
• Completion: 2023-09-02
• First posted: 2018-11-19
• Last updated: 2024-02-07

Locations

4 sites across 2 countries: Italy, Spain